Measurement of Refractive SE Following Implantation of LS313 MF30 IOL

NCT03292614 | Completed Results

• 1 other identifier: STI 02/17
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This Study determines the most precise method for measuring post-operative refraction following implantation of the asymmetric multifocal LS-313 MF30 comparing the results of Refraction of the different Autorefractor Keratometers with the subjective measurements for distance and near.

Conditions

Refractive Errors

Keywords

Multifocal Intraocular Lens; Postoperative Measurements of refraction

Outcome Measures

Primary Outcomes (1)

• Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30

  After the implantation of the LS 313 MF30 (a refractive, asymmetrical, multifocal intraocular lens), the most reliable refraction method so far has been the subjective determination of far and near refraction. A faster and widespread method is the measurement with auto-refractometers (KR-1W (TOPCON), KR-800s (TOPCON), ARK-560 (NIDEK), ARK-760A (NIDEK)) or manual refractometers (PR60/50 (Rodenstock)). KR-1W, KR-800s, ARK-560A, ARK-760A only allow a central measurement without separate measurement of the two optical zones. The manual refractometer PR60/50 (Rodenstock) is able to separately measure the different focal points of the multifocal lens using a light cone with 3 mm diameter. The test device iTrace (TraceyTechnologies): is also able to separately measure the different focal points of the multifocal lens, but uses a light cone with a diameter of about 1 mm. The results of all refractometers are compared with the subjective refraction.

  one year

Study Arms (1)

Multifocal intraocular lens implantation

Patients who have undergone a cataract surgery with implantation of a multifocal intraocular lens LS313 MF30, Oculentis Berlin, will be invited for Measurements of the postoperative refraction

Diagnostic Test: Measurements of the postoperative refraction

Interventions

Measurements of the postoperative refraction DIAGNOSTIC_TEST

The Measurements of the postoperative refraction will be performed with the following devices: Autorefractor Keratometers: Mod. ARK-760A (NIDEK CO,LTD, Gamagõri, Japan /OCULUS, Wetzlar, Germany), Mod. ARK-560A (NIDEK CO,LTD, Gamagõri, Japan /OCULUS, Wetzlar, Germany) KR-1W (TOPCON, Willich, Germany) KR-800s (TOPCON, Willich, Germany) Manual Refractometer: Eye refractometer PR 60 or PR 50 (Rodenstock, Munich), Test device: iTrace (TraceyTechnologies, Houston, Texas, USA), Phoropter (Block-Optic, Model 11625B) Determination of subjective refraction for distance and near (reading distance)

Multifocal intraocular lens implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

up to 100 eyes

You may qualify if:

• Patients after cataract surgery with implantation of the MICS-IOL LS-313 MF30 postoperative clear cornea willing to participate in the study

You may not qualify if:

• significant corneal opacities, history of keratoplasty, Anterior capsule phimosis, posterior capsular opacification if patients refuse Nd:YAG laser treatment of the secondary cataract

Sponsors & Collaborators

• Dietrich-Bonhoeffer-Klinikum: lead

Study Sites (1)

Dietrich-Bonhoeffer-Klinikum

Neubrandenburg, Mecklenburg-Vorpommern, 17036, Germany

Location

Related Publications (5)

• Kretz FT, Linz K, Mueller M, Gerl M, Koss MJ, Gerl RH, Auffarth GU. [Refraction after Implantation of Multifocal and Presbyopia-Correcting Intraocular Lenses]. Klin Monbl Augenheilkd. 2015 Aug;232(8):953-6. doi: 10.1055/s-0035-1545832. Epub 2015 Apr 30. German.

  PMID: 25927177 BACKGROUND

• Munoz G, Albarran-Diego C, Sakla HF. Validity of autorefraction after cataract surgery with multifocal ReZoom intraocular lens implantation. J Cataract Refract Surg. 2007 Sep;33(9):1573-8. doi: 10.1016/j.jcrs.2007.05.024.

  PMID: 17720072 BACKGROUND

• Bissen-Miyajima H, Minami K, Yoshino M, Nishimura M, Oki S. Autorefraction after implantation of diffractive multifocal intraocular lenses. J Cataract Refract Surg. 2010 Apr;36(4):553-6. doi: 10.1016/j.jcrs.2009.10.047.

  PMID: 20362844 BACKGROUND

• van der Linden JW, Vrijman V, Al-Saady R, van der Meulen IJ, Mourits MP, Lapid-Gortzak R. Autorefraction versus subjective refraction in a radially asymmetric multifocal intraocular lens. Acta Ophthalmol. 2014 Dec;92(8):764-8. doi: 10.1111/aos.12410. Epub 2014 Apr 27.

  PMID: 24767468 BACKGROUND

• Munoz G, Albarran-Diego C, Sakla HF. Autorefraction after multifocal IOLs. Ophthalmology. 2007 Nov;114(11):2100. doi: 10.1016/j.ophtha.2007.05.049. No abstract available.

  PMID: 17980752 BACKGROUND

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Ulrike Holland
• Organization: Dietrich-Bonhoeffer-Klinikum

aug-st2@dbknb.de

+49 395 775 3427

Study Officials

• Helmut Hoeh, MD, FEBO

  Department of Ophthalmology, Neubrandenburg, Germany

  PRINCIPAL INVESTIGATOR

• Vitaliy Klishko

  Department of Ophthalmology, Neubrandenburg, Germany

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 25, 2017
• Study Start: June 1, 2017
• Primary Completion: January 31, 2019
• Study Completion: June 1, 2019
• Last Updated: September 26, 2019
• Results First Posted: September 26, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)